Select Page

Home / News / BioBlast® / Biosimilar Deals 2021

EXPLORE OUR

Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Approval Alert: FDA Approves BMS’s Opdivo (nivolumab) in Combination with Cisplatin and Gemcitabine for Metastatic Urothelial Carcinoma

On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults with unresectable or metastatic urothelial carcinoma.   

Previously in February 2024 and in December 2023, BMS announced that the FDA accepted its sBLA for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) and also accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma. 

Study Finds that LG Chem’s Biosimilar LBEC0101 is Comparable to Pfizer & Amgen’s Enbrel (Etanercept) for Treatment of Patients With Rheumatoid Arthritis

On 5 March 2024, a study published in Modern Rheumatology found that LG Chem’s LBEC0101, the biosimilar of etanercept, matches up to the reference product in terms of effectiveness and safety in the real-world treatment of rheumatoid arthritis. This evidence was gathered from the Kyoto University Rheumatoid Arthritis Management Alliance cohort, including patients treated between 2015 and 2021. The study reports that patients who switched from the reference product to LBEC0101 did not experience any significant differences in their treatment outcomes.

Janssen Moves to Dismiss Insurers’ Stelara® Class Action

Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss a class action brought by several US health insurers alleging the companies unlawfully delayed biosimilar competition for Stelara® (ustekinumab) in the US.  J&J/Janssen argue that the alleged facts do not meet the standard of unlawful exclusionary conduct. 

The insurers filed the class action in the US District Court of East Virginia on 7 December 2023, alleging that the companies would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and implemented a scheme to unlawfully prolong patent protection.   

Fresenius Announces First Subcutaneous Tocilizumab Biosimilar Approved in the US

On 5 March 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Genentech’s/Roche’s Actemra®, for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  Tyenne® is the second FDA-approved tocilizumab biosimilar, following the approval of Biogen’s IV formulation Tofidence® in September 2023, but is the first approved subcutaneous formulation.  Tyenne® was approved by the FDA in both IV and subcutaneous forms. The US launch date for its tocilizumab products remains confidential following a patent settlement with Roche and Chugai in October 2022.   

Tyenne® has launched in more than 10 countries to date, including in Europe in November 2023 in both IV and subcutaneous formulations.  Fresenius reports that its global roll out will continue through 2024 and 2025. 

Sandoz Announces First US Denosumab Biosimilars Approved with Interchangeability

On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz’s Wyost® and Jubbonti®.  The biosimilars are interchangeable with, and approved for all indications of, Amgen’s Xgeva® and Prolia® respectively. 

The US launch date for the newly approved biosimilars is uncertain given ongoing BPCI litigation regarding the products, commenced by Amgen in May 2023 relating to 21 patents. 

The US approval comes weeks after Sandoz announced the approval of Jubbonti® in Canada.  Prolia® biosimilars developed by Boan Biotech and Mabwell were approved in China respectively in November 2022 (BA6101, Byoubei®) and March 2023 (Mailishu®). 

Novo Nordisk Ozempic® (Semaglutide 1.0) Study Demonstrates Reduction in Kidney Disease Events

Novo Nordisk announced the results of its Ozempic® (semaglutide 1.0mg) FLOW study kidney outcomes.  In this study, semaglutide 1.0 mg was compared to placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in more than 3,500 people with type 2 diabetes and chronic kidney disease (CKD).  The trial demonstrated a 24% reduction in kidney disease progression, major adverse cardiovascular events (MACE) and death in people treated with semaglutide 1.0 mg compared to placebo.  Novo Nordisk intends to file for regulatory approval for label expansion around the world in 2024. 

This comes as the company is addressing counterfeit products around the world as reported on 1 March 2024 and 5 February 2024.  

Indian Launch of Roche’s $2.7 Billion Blockbuster Vabysmo® (faricimab)

On 5 March 2024, the Times of India reported that Roche launched Vabysmo® (faricimab) in India for the treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME).    

Vabysmo® was first approved in the US by the FDA in January 2022 and is now available in multiple countries, including Europe, Canada and Australia.  In October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® to treat macular oedema following retinal vein occlusion.  Since its first launch date, Vabysmo ® has achieved global sales of US$2.7 billion.   

Phase II Clinical Trials Show Positive Results for FKB238 (bevacizumab biosimilar), Olaparib, and Durvalumab Combination for Treatment of Ovarian Cancer

A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by Arcagy-GINECO showed that FKB238 (bevacizumab biosimilar) + olaparib + durvalumab combination showed better survival for treatment of patients with relapsed ovarian cancer than patients with no treatmentBetween 1 March 2019 and 23 January 20202, a total of 74 patients were enrolled in nine French centres and were treated with the bevacizumab biosimilar FKB238 (15 mg/kg intravenously, once-every-3-weeks), olaparib (300 mg orally, twice daily), and durvalumab (1.12 g intravenously, once-every-3-weeks).  

Pearce IP BioBlast w/e 4 March 2024

The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized ‘off-brand’ Ozempic® (semaglutide) and other allegedly unlawfully made medications.  As reportedly revealed in a confidential TGA letter obtained by Australia’s national broadcaster, ABC, the TGA plans to ban the sale of pharmacy-made versions of Ozempic® due to serious safety concerns.  

The raid resulted in the seizure of compounded semaglutide, peptides, and human growth hormones.  

Ozempic® is manufactured by the Danish drug giant Novo Nordisk.  While it is primarily a diabetes medication, Ozempic® has gained popularity as a weight loss drug.  

The Financial Review reports that originator Novo Nordisk supports the ban, citing safety concerns and the need to halt pharmacy-made versions of its global blockbuster semaglutide product Ozempic®.   

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented a global increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  Jamteki was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding ustekinumab. 

Jamteki was developed by Alvotech and is JAMP Pharma’s second biosimilar launch in Canada in two years, following the Canadian launch of Simlandi® (adalimumab) biosimilar of AbbVie’s Humira® (adalimumab) in 2022.  The approved presentations for Jamteki™ are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

The Medicines and Healthcare Regulatory Agency issued a safety update regarding (dupilumab) and ocular side effects.  The regulator warned that side effects can include conjunctivitis and ulcerative keratitis

On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025.  The FDA previously accepted for review Biocon’s Biologics License Application for Bmab 1200. 

The settlement will result in the termination of the pending Inter Partes Review petition filed by Biocon in November 2023 against Janssen’s US method of treatment (severely active ulcerative colitis (UC)) patent 10,961,307 relating to Stelara® (ustekinumab). 

J&J and Janssen recently entered into ustekinumab settlements with Alvotech (launch dates of no later than 21 February 2025 (US), May 2024 (Japan), late July 2024 (EU) and Q1 2024 (Canada)), BioPharma (US launch date of 15 May 2025), Samsung Bioepis (US launch date from 22 February 2025), Celltrion (US launch date of 7 March 2025), Fresenius Kabi and Formycon (US launch date no later than 15 April 2025), and Amgen (US launch date no later than 1 January 2025).  To date, only Amgen has obtained FDA approval for its ustekinumab biosimilar, with its Wezlana® approved in October 2023. 

On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Xgeva® (denosumab) as a 120mg solution for injection in a prefilled syringe.  This Xgeva PFS product is a high concentration product which is a line extension of the original Xgeva® sold as a vial product containing 120mg solution for injection. 

This is the first product to be authorised by the MHRA via the new International Recognition Procedure (IRP) introduced in January this year.    

The IRP allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.  In fast-tracking the authorisation of the new Xgeva® high concentration formulation, the MHRA considered a positive opinion issued by the European Medicines Agency on 25 January 2024. 

On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab).  The application seeks registration across the full Actemra® label and is based on Phase 3 results confirming equivalence of CT-P47 to Actemra®.  Celltrion announced that it will use these results to accelerate applications for product approvals in other countries. 

This follows Celltrion’s announcement on 13 February 2024 that it submitted a Marketing Authorisation Application to the EMA for CT-P47.  On 28 January 2024, Celltrion also announced it had submitted a BLA in the US for CT-P47.  

On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with three more shipments expected to arrive by early March this year.  Zymfentra® was approved by the FDA in October 2023. 

Zymfentra® (SC infliximab), also known as Remsima SC in Europe, is the world’s first subcutaneous injection of infliximab.  Zymfentra® can be self-administered increasing patient convivence and reducing hospital burden.  Celltrion aims to distribute Zymfentra® to US wholesalers by mid-March.  

Zymfentra® was approved by the FDA in October 2023. 

On 27 February 2024, Akeso announced results of a Phase II clinical trial focadonilimab combined with standard treatment (chemotherapy +/- bevacizumab) for treating recurrent/metastatic cervical cancer The results were published in the American Association for Cancer Research’s Clinical Cancer Research journal and, amongst other things, the results showed that 63.6% of patients experienced tumour reduction of more than 50%. 

On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its supplemental Biologics License Application for EPKINLY® (epcoritamab) for the treatment of Adult Relapsed or Refractory Follicular Lymphoma (R/R FL).  Priority review will decrease the review time to six months, compared to a standard 10 months.  If approved by the FDA, EPKINLY® will be the first and only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy. 

On 25 September 2023, AbbVie announced that its Tepkinly® (epcoritamab) received conditional marketing authorisation to Treat R/R DLBCL from the European Commission. 

On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene’s Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine-and platinum-containing chemotherapy, with a PDUFA date set for December 2024.  The product is intended to offer improved treatment options for patients diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.  

On 19 September 2023, BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a termination of the previous arrangement between the parties.  Furthermore, BeiGene announced on 26 February 2024, that CHMP issued a positive opinion for its TEVIMBRA® (tislelizumab) to treat NSLC. 

On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the use of Voydeya® (danicopan) as an add-on to ravulizumaboreculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.   

CHMP based its positive opinion on results from the ALPHA Phase III trial which were published in The Lancet Haematology journal on 27 November 2023.  

On 26 February 2024, BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of TEVIMBRA® (tislelizumab) for the treatment of non-small cell lung cancer (NSCLC). The indications include treatment of squamous, non-squamous and locally advanced / metastatic NSCLC. BeiGene’s Phase 3 clinical trials, enrolling 1,500 patients, showed tislelizumab to be an effective therapy for patients with treatment-naive and treatment-resistant NSCLC. 

On 19 September 2023, BeiGene announced it regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following termination of the previous arrangement between the parties. 

On 26 February 2024, the results of an 18 month study sponsored by Takeda Pharmaceuticals were published in Crohn’s & Colitis 360.  The study involved 108 patients switched from IV to a subcutaneous vedolizumab.  The results of the study suggested that switching from an intravenous to a subcutaneous treatment of vedolizumab is convenient and safe. 

On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of Food and Drug Safety for Afilivu®, biosimilar to Regeneron’s Eylea® (aflibercept).  This is the first aflibercept biosimilar approved in Korea and Samsung Bioepis’ second biosimilar for ophthalmic disease, after its Lucentis® (ranibizumab) biosimilar – Amelivu® – was approved in Korea in May 2022.  Afilivu® is indicated for treatment of wAMD, RVO, DME and mCNV.   

As previously reported, Samsung Bioepis will co-market Afilivu® in Korea with Samil Pharmaceutical, together with ranibizumab biosimilar Amelivu®. 

In the US, aflibercept biosimilars are the subject of patent infringement litigation commenced by Regeneron against Samsung BioepisAmgenFormyconCelltrion and Mylan and Biocon.  In Europe, Formycon announced in December 2023 that the EMA had accepted its marketing authorisation application for its aflibercept biosimilar FYB203. Biocon has received marketing approval for its aflibercept biosimilar Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). Formycon announced in December 2023 that the EMA had accepted its application for its aflibercept biosimilar FYB203. 

On 26 February 2024, Alvotech announced the sale of 10,127,132 ordinary shares at a purchase price of USD 16.41 per share.  Alvotech’s U.S listed shares rose more than 12% to $18 in premarket trading following the announcement on 23 February 2024 that FDA approved Alvotech’s SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to AbbVie’s Humira®.  

Coherus Bioscience announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®.  Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.  The on-body injector utilises LTS Lohmann Therapie-Systeme AG’s wearable drug delivery platform. 

Udenyca OnBody® received FDA approval in December 2023. 

On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals regarding the Patent Trial and Appeal Board’s (PTAB) decision in IPR2022-00578 and IPR2022-00579 The motion records that Celltrion (the petitioner) has not formally agreed to the dismissal and may file a response. 

Previously, Celltrion filed inter partes review (IPR) petitions IPR2022-00578 against Chugai/Genentech/Roche’s MOT (RA) patent no. US8580264 (‘264), and IPR 2022-00579 against Chugai/Roche’s device patent no. US10874677 (‘677).  The PTAB concluded that claims 1-12 of the ‘264 MOT patent and claims 1-8 of the ‘677 patent are invalid in view of the prior art.  Chugai, Genentech, and Hoffmann-La Roche appealed PTAB’s decision and are now seeking to have that appeal dismissed.

On 31 January 2024, the US District Court for the Northern District of West Virginia published a redacted version of Judge Thomas Kleeh’s Memorandum Opinion and Order, setting out the detailed reasons for his previous finding that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®.  The Judge found asserted claims of two method of treatment patents (11,253,572 and 10,880,601) to be invalid.   

The infringement finding was made in relation to the aflibercept biosimilar Yesafili®.  Mylan filed a Biologics Licence Application (BLA) for Yesafili® in October 2021 seeking FDA approval to market it.  Mylan’s rights in the Yesafili® BLA were later transferred to Biocon, who intended to sell the product in the US. 

On 27 December 2023, Judge Kleeh issued a short-form judgment setting out his conclusions.  At that time, the detailed reasons remained under seal.  Mylan and Biocon and Regeneron filed “protective” notices of appeal from the short form judgment on 26 January 2024, although the parties allege that the 27 December judgment was not a final, appealable one. 

Biocon has received marketing approval for Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). 

Regeneron filed a complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting 51 counts of patent infringement.  This is the second suit filed against Samsung Bioepis in the Regeneron aflibercept matters, the first of which was filed on 21 November 2023.  

Samsung has filed IPR petitions against a number of Regeneron aflibercept patents including  US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 on April 2023US10,888,601 on April 2023 and US10,130,681 on January 2023. 

An AbbVie sponsored phase 3 study evaluating risankizumab for treatment of Crohn’s disease shows that risankizumab performs better than ustekinumab in primary and secondary endpoints. The study compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s disease. The safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified. 

In November 2023, the Korean MFDS approved AbbVie’s Skyrizi® (risankizumab) to treat Chron’s disease. 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assists with office actions. 

With a background in physiology, Faran is passionate about life sciences industries.  His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.   

Sandoz Completes Acquisition of Coherus’s CIMERLI® (ranibizumab biosimilar)

On 4 March 2024, Sandoz announced the completion of its acquisition of biosimilar CIMERLI® (ranibizumab) from Coherus BioSciences. This VEGF inhibitor ranibizumab was approved by the FDA on 2 August 2022 and is indicated for the treatment of retinal diseases. The acquisition includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software. Sandoz announced its USD $170M deal to acquire CIMERLI® on 22 January 2024, and now reports that the deal was completed ahead of schedule.  

Amgen Launches Second Stelara® (ustekinumab) Biosimilar in Canada

Amgen announced that Wezlana™ (ustekinumab injection) and Wezlana™ (ustekinumab for injection, solution for intravenous infusion), biosimilar to Janssen’s Stelara®, is now available in Canada.  Wezlana™ is the first biosimilar to be approved by Health Canada for all Stelara® indications, but the second ustekinumab Canadian launch following the launch of  the first ustekinumab biosimilar (Jamteki™) in Canada by JAMP Pharma on 1 March 2024.   

Jamteki™ was developed by Alvotech and was approved by Health Canada in November 2023. 

Biocon Settles Aflibercept Dispute with Regeneron & Bayer; Announces Canadian Launch Date

Biocon announced a settlement with Regeneron and Bayer under which it can launch its Yesafili® (aflibercept), biosimilar to Regeneron’s Eylea®, in Canada from 1 July 2025.  The settlement resolves multiple patent infringement proceedings in the Federal Court of Canda involving six patents relating to aflibercept.  The settlement does not appear to have resolved disputes beyond Canada, there being no impact to the ongoing US aflibercept dispute between Biocon and Regeneron.   

Yesafili® was granted tentative approval by Health Canada in March 2023, subject to resolution of patent issues.  Yesafili® was approved in the UK in November 2023 and in EU in September 2023. 

A Second Challenge by Merck Against Four Johns Hopkins Pembrolizumab MOT Patents

On 4 March 2024, Merck filed petitions for inter partes review against four Johns Hopkins University (JHU) patents relating to methods of treatment using pembrolizumab in patients whose cancers have a genetic instability called microsatellite instability-high (MSI-H).    These four IPRs are IPR2024-00622 (against US10,934,356), IPR2024-00623 (against US11,325,974), IPR2024-00624 (against US11,325,975), and IPR2024-00625 (against US11,339,219).  Each IPR is based on anticipation and obviousness.  The petitions have not yet been instituted by the USPTO.

In November 2022 Merck filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel in relation to the same four patents.   The trial has not yet been scheduled.

Authorities raid Como Compounding Pharmacy in Melbourne and Seize Semaglutide

The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized ‘off-brand’ Ozempic® (semaglutide) and other allegedly unlawfully made medications.  As reportedly revealed in a confidential TGA letter obtained by Australia’s national broadcaster, ABC, the TGA plans to ban the sale of pharmacy-made versions of Ozempic® due to serious safety concerns.  

The raid resulted in the seizure of compounded semaglutide, peptides, and human growth hormones.  

Ozempic® is manufactured by the Danish drug giant Novo Nordisk.  While it is primarily a diabetes medication, Ozempic® has gained popularity as a weight loss drug.  

The Financial Review reports that originator Novo Nordisk supports the ban, citing safety concerns and the need to halt pharmacy-made versions of its global blockbuster semaglutide product Ozempic®.   

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented a global increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

First Biosimilar Launch: JAMP Pharma Launches Alvotech-Developed Jamteki™ (ustekinumab) in Canada

On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  Jamteki was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding ustekinumab. 

Jamteki was developed by Alvotech and is JAMP Pharma’s second biosimilar launch in Canada in two years, following the Canadian launch of Simlandi® (adalimumab) biosimilar of AbbVie’s Humira® (adalimumab) in 2022.  The approved presentations for Jamteki™ are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

The Next Chapter in the Carpark Patent Saga: The Full Court’s Decision on Infringement and Best Method

Date:

Court:

Judge:

9 February 2024

Full Federal Court of Australia

Burley, Jackson and Downes JJ

SARB partially successful in carpark overstay patent appeal

The Federal Court’s second patent decision of 2024 is a unanimous decision of the Full Federal Court relating to one of several long-running patent disputes in the field of carpark overstay detection.   In March 2023, Justice Besanko upheld the validity of two patents owned by Vehicle Monitoring Systems Pty Ltd (VMS), both entitled ‘Method, apparatus and system for parking overstay detection’.  His Honour also held that three versions of a vehicle detection and sensor system known as ‘PinForce’ sold by SARB Management Group Pty Ltd were infringing, with the first two versions infringing claims of both patents and the third version infringing only claims of one of the patents.  We reported Justice Besanko’s decision in an earlier blog.

Construction and infringement

SARB’s appeal to the Full Federal Court on infringement was confined to the finding regarding PinForce version 3 in respect of the one patent held to have been infringed by this version. Key to Justice Besanko’s infringement finding was the  construction of claim features directed to the step of determining whether a vehicle has overstayed, and particularly whether this determination is  carried out by the wireless ‘data collection apparatus’ (DCA) rather than solely by the ‘detection apparatus’ (DA) located beneath the carpark space.  Before Justice Besanko, all experts agreed that in the case of PinForce Version 3, all capability of determining overstay in the DA had been removed following a redesign.  The Full Court overturned  Justice Besanko’s decision finding that the claims should be construed to encompass a system where vehicle detection is determined only by the DA (not the DCA).  The effect of this change in construction was that the PinForce version 3 system fell outside the patent claims.

Best method

SARB also appealed the primary judge’s decision on validity, specifically his finding that SARB failed to establish that the two patents were invalid on the ground of best method.  Before Justice Besanko, SARB had  argued that the patent did not include the best method known to the patentee  of communicating data from the subterraneous DA using a functioning wake-up scheme because the patent did not describe the use in this scheme of a specific transceiver (the ASTRX2 transceiver), even though it was known to the inventor to have advantages which made it the best transceiver for communicating data from the subterraneous detection apparatus.   The Full Court, however, agreed with Justice Besanko that the invention disclosed in the two patents related to the wake-up scheme and not the wake-up scheme as carried out by a transceiver with particular features.   In reaching this conclusion, the Full Court emphasised the significance of the embodiments in the specification in identifying the invention, whereas SARB had focussed on the consistory clauses to the challenged claims.  The Court held the disclosure was adequate because the parameters of the wake-up scheme were clearly disclosed in the specification, and there was no evidence that transceivers other than the ASTRX2 could not meet these parameters.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Helen Macpherson

Helen Macpherson

Executive, Lawyer

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information across a wide range of industries, including the pharmaceutical/biopharmaceutical, biotechnology, medical device, life sciences, agricultural, manufacturing and tech sectors.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chris Vindurampulle PhD

Chris Vindurampulle PhD

Executive, Patent & Trade Mark Attorney

Chris is a senior Patent and Trade Mark Attorney who is registered to practice before the intellectual property offices of Australia and New Zealand.  He is experienced in patent drafting, patent and trade mark prosecution and opposition, and freedom to operate, opinion and due diligence work.  Through his experience and delivery of highly-regarded client service, Chris has been recognised as a leading patent practitioner having been listed in the IAM Patent 1000 as a recommended individual for patent prosecution, and a Rising Star in 2021, 2022 and 2023 by Managing IP.

Biocon and J&J Ustekinumab Settlement, and Biocon’s US Launch Planned for Feb 2025

On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025.  The FDA previously accepted for review Biocon’s Biologics License Application for Bmab 1200. 

The settlement will result in the termination of the pending Inter Partes Review petition filed by Biocon in November 2023 against Janssen’s US method of treatment (severely active ulcerative colitis (UC)) patent 10,961,307 relating to Stelara® (ustekinumab). 

J&J and Janssen recently entered into ustekinumab settlements with Alvotech (launch dates of no later than 21 February 2025 (US), May 2024 (Japan), late July 2024 (EU) and Q1 2024 (Canada)), BioPharma (US launch date of 15 May 2025), Samsung Bioepis (US launch date from 22 February 2025), Celltrion (US launch date of 7 March 2025), Fresenius Kabi and Formycon (US launch date no later than 15 April 2025), and Amgen (US launch date no later than 1 January 2025).  To date, only Amgen has obtained FDA approval for its ustekinumab biosimilar, with its Wezlana® approved in October 2023. 

Amgen High Concentration PFS Xgeva® (denosumab) Approved by UK MHRA in 30 Days under New International Recognition Procedure

On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Xgeva® (denosumab) as a 120mg solution for injection in a prefilled syringe.  This Xgeva PFS product is a high concentration product which is a line extension of the original Xgeva® sold as a vial product containing 120mg solution for injection. 

This is the first product to be authorised by the MHRA via the new International Recognition Procedure (IRP) introduced in January this year.    

The IRP allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.  In fast-tracking the authorisation of the new Xgeva® high concentration formulation, the MHRA considered a positive opinion issued by the European Medicines Agency on 25 January 2024. 

Celltrion files Korean Application for CT-P47, Tocilizumab Biosimilar

On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab).  The application seeks registration across the full Actemra® label and is based on Phase 3 results confirming equivalence of CT-P47 to Actemra®.  Celltrion announced that it will use these results to accelerate applications for product approvals in other countries. 

This follows Celltrion’s announcement on 13 February 2024 that it submitted a Marketing Authorisation Application to the EMA for CT-P47.  On 28 January 2024, Celltrion also announced it had submitted a BLA in the US for CT-P47.  

Celltrion’s Zymfentra® (SC infliximab) launched in US

On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with three more shipments expected to arrive by early March this year.  Zymfentra® was approved by the FDA in October 2023. 

Zymfentra® (SC infliximab), also known as Remsima SC in Europe, is the world’s first subcutaneous injection of infliximab.  Zymfentra® can be self-administered increasing patient convivence and reducing hospital burden.  Celltrion aims to distribute Zymfentra® to US wholesalers by mid-March.  

Zymfentra® was approved by the FDA in October 2023. 

Stuck in the Mud: 4WD storage system patent valid but not infringed

Date:

Court:

Judge:

24 January 2024

Federal Court

Downes J

In the first Federal Court patent decision handed down in 2024, MSA 4×4 Accessories Pty Ltd failed to establish infringement by Clearview Towing Mirrors Pty Ltd of MSA’s patent to a mountable storage device, commonly used in off-road and trade vehicles.  The blow was compounded by the Court upholding Clearview’s claim of unjustified threats of infringement under s 128 of the Patents Act 1990 (Cth) and contravention of s 18 of the Australian Consumer Law (ACL) regarding external communications by or on behalf of MSA.  Although moot given the finding of non-infringement, the Court rejected Clearview’s validity challenge.  Significantly, the Court rejected or gave no weight to key parts of Clearview’s expert evidence on obviousness, pointing to significant deficiencies in its preparation.

MSA, as exclusive licensee, and the patentee (a director of MSA), asserted infringement by Clearview of Australian patent AU2009245888 (Patent).  The Patent is directed to a slide-out apparatus for holding and storing items in vehicles, marketed under the name MSA4X4 DropSlide™.  Clearview’s “Easy Slide” product, designed for the same purpose, was at the centre of the infringement dispute.

Unjustified threats

The Court’s finding of non-infringement was not automatically determinative of the unjustified threats counterclaim.   These counterclaims related to two announcements sent by MSA to customers and potential customers, while a further unjustified threats claim related to a letter from the lawyers for MSA and the patentee.  Despite acknowledging that the Court has typically found infringement threats to be unjustified where a patent is held not infringed, Justice Downes held that this will not always be the case.

While differing in tone, all the communications referred to the potential for Clearview to bring infringement proceedings.  However, both the first announcement and the lawyer’s letter specifically referred to the Clearview Easy Slide product infringing the Patent, while the second announcement did not specifically refer to the Clearview product.  This appeared to be key to the Court’s finding that the former constituted a threat of infringement while the latter did not, although the ‘strident’ tone of the first announcement was also a factor.

Having made this finding, the Court then found that MSA and the patentee had failed to discharge their onus to demonstrate why these threats were not unjustified in light of the non-infringement finding.  The ACL claim followed the finding on unjustified threats.

The obviousness case and expert evidence

Clearview’s invalidity case ultimately failed.  While moot given the non-infringement finding, her Honour’s judgment on invalidity is a salient reminder of the expectations of Australian courts when it comes to the preparation of expert evidence.

Justice Downes excluded some expert evidence led by Clearview on obviousness because the expert had been provided with the Patent before giving his evidence on his knowledge and experience as at the Patent’s priority date.  Her Honour accepted that it is not a blanket rule that expert evidence should always be excluded when the expert had reviewed the patent in suit prior to giving evidence on the issue of obviousness. However, in this case there was no evidence that Clearview’s lawyers had instructed him on what it meant for an invention to be “obvious” as that term is understood in patent litigation. There was also insufficient evidence to demonstrate what the expert understood “obvious” to mean when he expressed his opinions. Her Honour therefore determined not to admit key paragraphs of the expert’s first affidavit into evidence.

Justice Downes also gave no weight to the expert’s evidence as to the approach he would have taken to a hypothetical ‘design task’ because the design task parameters provided to the expert included parameters which did not form part of the common general knowledge at the priority date.  Her Honour further held that the framing of the design task infected the expert’s evidence on obviousness as it impermissibly enlarged the “body of knowledge and information” against which inventive step was to be tested, which was contrary to principle, and infected the expert’s evidence.

Finally, Justice Downes identified significant shortcomings in Clearview’s evidence as to whether one of the prior art documents would have been “ascertained, understood, [and] regarded as relevant” at the priority date, as required by the Patents Act 1990 (Cth) in its pre-Raising the Bar form.  In particular, her Honour was not persuaded that the expert would have searched Google Patents which became available only a year before the priority date. Nor was her Honour persuaded that the expert would have used the search terms set out in his affidavit evidence, given the choice of search terms was likely impermissibly influenced by exposure to the Patent and the design task parameters (which included parameters that did not form part of the common general knowledge as at the priority date).

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Helen Macpherson

Helen Macpherson

Executive, Lawyer

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information across a wide range of industries, including the pharmaceutical/biopharmaceutical, biotechnology, medical device, life sciences, agricultural, manufacturing and tech sectors.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chris Vindurampulle PhD

Chris Vindurampulle PhD

Executive, Patent & Trade Mark Attorney

Chris is a senior Patent and Trade Mark Attorney who is registered to practice before the intellectual property offices of Australia and New Zealand.  He is experienced in patent drafting, patent and trade mark prosecution and opposition, and freedom to operate, opinion and due diligence work.  Through his experience and delivery of highly-regarded client service, Chris has been recognised as a leading patent practitioner having been listed in the IAM Patent 1000 as a recommended individual for patent prosecution, and a Rising Star in 2021, 2022 and 2023 by Managing IP.

Akeso Announces Phase 2 Clinical Study Results for Cadonilimab

On 27 February 2024, Akeso announced results of a Phase II clinical trial for cadonilimab combined with standard treatment (chemotherapy +/- bevacizumab) for treating recurrent/metastatic cervical cancer The results were published in the American Association for Cancer Research’s Clinical Cancer Research journal and, amongst other things, the results showed that 63.6% of patients experienced tumour reduction of more than 50%. 

FDA Grants Priority Review of AbbVie’s sBLA for EPKINLY® (epcoritamab SC)

On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its supplemental Biologics License Application for EPKINLY® (epcoritamab) for the treatment of Adult Relapsed or Refractory Follicular Lymphoma (R/R FL).  Priority review will decrease the review time to six months, compared to a standard 10 months.  If approved by the FDA, EPKINLY® will be the first and only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy. 

On 25 September 2023, AbbVie announced that its Tepkinly® (epcoritamab) received conditional marketing authorisation to Treat R/R DLBCL from the European Commission.